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Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist
Ubrogepant for Pediatric Migraine
Verified Trial
Phase 3
Recruiting
Research Sponsored by Allergan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Do you child’s migraines last between 3-72 hours if untreated?
Has your child had migraines for at least 6 months?
Must not have
History of 1 to 14 migraine attacks per month with moderate to severe headache in each of the 2 months prior to screening (Visit 1).
Timeline
Screening 3 days
Treatment Varies
Follow Up 3 days
Awards & highlights
Study Summary
This trial is evaluating the safety and effectiveness of ubrogepant for the acute treatment of migraines in children and adolescents.
Who is the study for?
This trial is for children and adolescents aged 6-17 with a history of migraines, experiencing 1-14 attacks per month. They must have tried at least one oral migraine medication and their migraines should last between 3-72 hours if untreated. Exclusions include drug abuse, certain gastrointestinal conditions, specific types of migraines like hemiplegic or retinal, significant neurological disorders other than migraine, frequent hospital treatments for migraines, suicide risk, hypersensitivity to CGRP receptor antagonists or any study components.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of Ubrogepant—an approved adult migraine treatment—in young patients during acute migraine episodes. Participants will be split into two age groups (6-11 and 12-17) and randomly assigned to receive either a low or high dose of Ubrogepant or a placebo in a double-blind manner. There's a chance they'll get the placebo instead of the actual drug.See study design
What are the potential side effects?
While not specified here, common side effects from similar medications may include nausea, dry mouth, drowsiness, fatigue and potential allergic reactions. The exact side effects related to Ubrogepant in this age group will be monitored throughout the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child's migraines last from 3 to 72 hours without treatment.
Select...
My child has had migraines for at least 6 months.
Select...
I have tried at least one over-the-counter oral medication for my child's migraines.
Select...
My child experiences 1-14 migraine attacks monthly.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had 1 to 14 moderate to severe migraines each month for the last 2 months.
Timeline
Screening ~ 3 days1 visit
Treatment ~ Varies
Follow Up ~ 3 days1 visit
Screening ~ 3 days
Treatment ~ Varies
Follow Up ~3 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of participants with Pain Freedom at 2 Hours After the Initial Dose in pediatric participants aged 6 to 17 years
Secondary outcome measures
Change From Baseline in Electrocardiograms (ECGs) in pediatric participants aged 6 to 17 years
Number of Participants with Adverse Events (AE)
Percentage of Participants With Absence of the Most Bothersome Migraine-Associated Symptom Identified at Baseline at 2-Hours After Initial Dose in pediatric participants aged 12 to 17 years
+12 moreTrial Design
8Treatment groups
Experimental Treatment
Placebo Group
Group I: PK Cohort: Ubrogepant Dose BExperimental Treatment1 Intervention
Participants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study.
Group II: PK Cohort: Ubrogepant Dose AExperimental Treatment1 Intervention
Participants aged 6 to 11 will receive oral tablets of ubrogepant for PK analysis to determine appropriate dose for main study.
Group III: Main Study: Children Ubrogepant Low DoseExperimental Treatment1 Intervention
Participants aged 6 to 11 (after dose selection) will receive oral tablets of low dose ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, 2 to 24 hours after initial dose for headache of moderate/severe intensity.
Group IV: Main Study: Children Ubrogepant High DoseExperimental Treatment1 Intervention
Participants aged 6 to 11 (after dose selection) will receive oral tablets of high dose ubrogepant Dose B for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, 2 to 24 hours after initial dose for headache of moderate/severe intensity.
Group V: Main Study: Adolescents Ubrogepant Low DoseExperimental Treatment1 Intervention
Participants aged 12 to 17 will receive oral tablets of ubrogepant low dose for qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, 2 to 24 hours after initial dose for headache of moderate/severe intensity.
Group VI: Main Study: Adolescents Ubrogepant High DoseExperimental Treatment1 Intervention
Participants aged 12 to 17 will receive oral tablets of ubrogepant high dose or qualifying migraine attack. Participants have the option to take a second dose of ubrogepant or rescue medication, 2 to 24 hours after initial dose for headache of moderate/severe intensity.
Group VII: Main Study: Children Ubrogepant PlaceboPlacebo Group1 Intervention
Participants aged 6 to 11 (after dose selection) will receive oral tablets of placebo-matching ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of placebo-matching ubrogepant or rescue medication, 2 to 24 hours after initial dose for headache of moderate/severe intensity.
Group VIII: Main Study: Adolescents Ubrogepant PlaceboPlacebo Group1 Intervention
Participants aged 12 to 17 will receive oral tablets of placebo-matching ubrogepant for qualifying migraine attack. Participants have the option to take a second dose of placebo-matching ubrogepant or rescue medication, 2 to 24 hours after initial dose for headache of moderate/severe intensity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ubrogepant
2016
Completed Phase 4
~4990
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
AllerganLead Sponsor
781 Previous Clinical Trials
275,510 Total Patients Enrolled
9 Trials studying Migraine
4,810 Patients Enrolled for Migraine
AbbVieLead Sponsor
956 Previous Clinical Trials
500,291 Total Patients Enrolled
9 Trials studying Migraine
6,600 Patients Enrolled for Migraine
ABBVIE INC.Study DirectorAbbVie
395 Previous Clinical Trials
145,005 Total Patients Enrolled
9 Trials studying Migraine
6,600 Patients Enrolled for Migraine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can swallow pills or can learn to do so.I have tried at least one over-the-counter oral medication for my child's migraines.I have had 1 to 14 moderate to severe migraines each month for the last 2 months.You have expressed thoughts of hurting yourself or others in the past 6 months, or have attempted to hurt yourself in the past 6 months.You have had a bad reaction to a medication known as a CGRP receptor antagonist, ubrogepant, or any of the ingredients used in the study.I have had stomach or bowel problems that could affect how my body handles medication.My migraines usually last 3-72 hours and I have pain-free periods of at least 48 hours between them.I do not have any major health issues affecting my blood, hormones, lungs, kidneys, liver, stomach, heart, or nervous system.I have a history of severe migraines with specific symptoms.You have other medical conditions, such as severe headaches or mental health disorders, which may affect the study results according to the investigator's opinion.My child has had migraines for at least 6 months.I have taken medication for migraines before.I've been hospitalized for migraines 3+ times in the last 6 months.My child experiences 1-14 migraine attacks monthly.My child's migraines last from 3 to 72 hours without treatment.At the first visit, the doctor decides that you are currently abusing or dependent on drugs or alcohol.I have been diagnosed with migraines for at least 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Main Study: Adolescents Ubrogepant High Dose
- Group 2: Main Study: Children Ubrogepant Placebo
- Group 3: Main Study: Adolescents Ubrogepant Placebo
- Group 4: Main Study: Adolescents Ubrogepant Low Dose
- Group 5: Main Study: Children Ubrogepant High Dose
- Group 6: PK Cohort: Ubrogepant Dose B
- Group 7: Main Study: Children Ubrogepant Low Dose
- Group 8: PK Cohort: Ubrogepant Dose A
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 90 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 3 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people of age for this experiment being accepted currently?
"Children aged 6 to 17 years old may participate in this clinical trial, provided they meet the other eligibility criteria."
Answered by AI
Could I possibly participate in this research?
"This study is looking for 1059 individuals that suffer from migraines and are between 6-17 years old. Most importantly, applicants should meet the following criteria: A history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD-3) for at least 6 months., By history, the participant's migraines typically last between 3 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom., Weight is ≥ 20 kg (44 pounds) and < 135 kg (298 pounds), The participant is able to understand and complete the"
Answered by AI
Is this an original study?
"Allergan's Ubrogepant has been trialed 8 times since the drug's initial Phase 3 study in 2022. The most recent trial is still ongoing and involves 102 cities across 2 countries. 1059 patients were involved in the original study."
Answered by AI
In how many different medical clinics is this trial being run today?
"There are over 100 recruitment sites for this clinical trial, but a few notable ones include Pantheon Clinical Research in Bountiful, Utah, OnSite Clinical Solutions in Hickory, North carolina, and Practical Approach Pediatrics in San Antonio, Texas."
Answered by AI
Could you please detail any other instances where Ubrogepant has been tested?
"The first study of ubrogepant was completed in 2022 at Ponce Medical School Foundation /ID# 250612. There have been 8 studies total with 2 more recruiting patients as of now. Most of these studies are being conducted in Bountiful, Utah."
Answered by AI
Is Ubrogepant likely to lead to any adverse effects?
"Ubrogepant is in Phase 3 of clinical trials, which means that while there is data supporting its efficacy, multiple rounds of testing have shown it to be safe."
Answered by AI
Are people with the specific condition under study presently able to enroll in this trial?
"According to the website clinicaltrials.gov, this particular trial is still looking for participants. The study was posted on 1/13/2022 and has been edited as recently as 11/14/2022."
Answered by AI
How many people are being welcomed into this experiment?
"1059 patients that meet the prerequisites will be needed to carry out this research project. The sponsor, Allergan, plans to manage the trial from several locations; two being Pantheon Clinical Research /ID# 250703 in Bountiful, Utah and OnSite Clinical Solutions, LLC - Charlotte /ID# 227994 in Hickory, North carolina."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
What site did they apply to?
Advanced Research Center /ID# 227962
Children's Hospital Los Angeles /ID# 230596
Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 231738
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
Treatment failures with oral migraine meds.
PatientReceived 2+ prior treatments
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